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NCT Number: NCT03299894

Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department

The delayed administration of an adequate antimicrobial therapy is a strong predictor of impaired outcome in patients with bacterial sepsis. Therefore, the current Surviving Sepsis Campaign guidelines (2016) recommend that administration of intravenous antimicrobials be initiated within one hour following the recognition of sepsis or septic shock.

The quick Sepsis-related Organ Failure Assessment (qSOFA) score is a new bedside tool which has been recently proposed by the Third International Sepsis Consensus Definitions Task Force (Sepsis-3) to identify patients with suspected infection who are at greater risk for a poor outcome outside the Intensive Care Unit (ICU). It uses three criteria, assigning one point for low systolic blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min) and altered mentation (Glasgow coma scale <15). The score ranges from 0 to 3 points. A qSOFA value ≥2 points is associated with a greater risk of death or prolonged ICU stay, these outcomes being more common in infected patients who may be septic than in those with uncomplicated infection. The definite goal of qSOFA is to hasten the management and thus improve the outcome of patients at risk of sepsis or septic shock.

Many patients admitted to the hospital for bacterial sepsis or septic shock are initially managed in the Emergency Department (ED). This study aims at investigating whether the routine calculation of qSOFA at patient triage may hasten the initiation of antimicrobial therapy in patients admitted to the ED with suspected or proven bacterial infection, especially in those with subsequent criteria for sepsis or septic shock (Sepsis-3 definition).

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Key information

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional Hospital center of Orleans

Orléans, 45067, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected or proven bacterial infection at emergency department triage

Exclusion criteria

  • Imminent death
  • Pregnancy
  • Breast-feeding
  • For patients managed by a medicalized pre-hospital emergency team before ED admission : administration of a first dose of antimicrobial agent before ED admission
  • Lack of coverage by the public health insurance system
  • Patient's refusal for study enrollment
  • Lack of confirmed bacterial infection (i.e., documented either clinically, microbiologically or by imaging procedures) in patients with a suspected bacterial infection at emergency departement triage

Treatment and study plan

systematic calculation of qSOFA

Procedure

calculation of qSOFA for each patient

Primary outcomes

  1. Proportion of patients who receive a first dose of antimicrobial agent

    Time frame: one hour

    Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) who receive a first dose of antimicrobial agent within one hour following triage in the emergency department.

Secondary outcomes

  1. Proportion of patients who receive a first dose of adequate antimicrobial agent

    Time frame: one hour

    Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) and microbiologically documented infection who receive a first dose of adequate antimicrobial agent within one hour following triage in the emergency department.

  2. Proportion of patients who receive a first dose of antimicrobial agent

    Time frame: three hours

    Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) who receive a first dose of antimicrobial agent within 3 hours following triage in the emergency department.

  3. Proportion of patients who receive a first dose of adequate antimicrobial agent

    Time frame: three hours

    Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) and a microbiologically documented infection who receive a first dose of adequate antimicrobial agent within 3 hours following triage in the emergency department

  4. Proportion of patients with a decrease in SOFA score value ≥ 1 point

    Time frame: two days

    Proportion of patients with a decrease in SOFA score value ≥ 1 point between triage in the emergency department (Day 0) and Day 2 among those with an initial SOFA score value ≥ 1 point

  5. Proportion of patients requiring an admission to the Intensive Care Unit

    Time frame: two days

    Proportion of patients requiring an admission to the Intensive Care Unit between triage in the emergency department (Day 0) and Day 2

  6. In-hospital mortality at day 7

    Time frame: seven days

    Number of patients who died in hospital at day 7

  7. Overall In-hospital mortality

    Time frame: through hospital discharge, up to 3 months

    Number of patients who died in hospital during the hospital stay

  8. Length of hospital stay

    Time frame: throught hospital discharge, up to 3 months

    Number of days in hospital

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Usefulness of Routine qSOFA Calculation at Triage to Fasten Antimicrobial Administration in Patients With Bacterial Infection in the Emergency Department: a Quasi-experimental Study

Acronym: qSOFAST

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2017
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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